Clemens MW, Kronowitz SJ. TheraSkin is most commonly used in the treatment of partial and full-thickness wounds including chronic wounds, pressure ulcers, diabetic foot ulcers, venous stasis ulcers and burns. It is an acellular dermal tissue matrix derived from fetal or neonatal bovine dermis and is intended for implantation to reinforce soft tissue where weakness exists and for the surgical repair of damaged or ruptured soft tissue membranes. Tong E, Martin F, Shelley O. 2003;12(3):101-107. Sepesi B, Moalem J, Galka E,et al. Arch Surg. Accessed February 13, 2019. #: FL1-00061-en-USVersion: GLanguage: EnglishRevision Date: 10/18/2022, 2023 Coding and Reimbursement Guide for the NanoScope Operative Arthroscopy System, 2023 Coding and Reimbursement Guidelines for Achilles Soft-Tissue Implants, 2023 Coding and Reimbursement Guidelines for Arthrex Amnion Matrix, 2023 Coding and Reimbursement Guidelines for Autograft OATS, 2023 Coding and Reimbursement Guidelines for CuffMend Rotator Cuff Repair Augmentation System, 2023 Coding and Reimbursement Guidelines for FastThread Interference Screws, 2023 Coding and Reimbursement Guidelines for Hand/Wrist Anchors Soft Tissue Implants, 2023 Coding and Reimbursement Guidelines for Meniscal Allograft Transplant Procedure, 2023 Coding and Reimbursement Guidelines for Metal Compression FT Screws, 2023 Coding and Reimbursement Guidelines for PushLock, 2023 Coding and Reimbursement Guidelines for the AutoCart Procedure Using GraftNet Autologous Tissue Collector & BioCartilage, 2023 Coding and Reimbursement Guidelines for the BicepsButton Implant and Pec Button, 2023 Coding and Reimbursement Guidelines for the BioSurge Convenience Kit, 2023 Coding and Reimbursement Guidelines for the Corkscrew, 2023 Coding and Reimbursement Guidelines for the Eclipse Total Shoulder System, 2023 Coding and Reimbursement Guidelines for the FiberTak, 2023 Coding and Reimbursement Guidelines for the Foot/Ankle, 2023 Coding and Reimbursement Guidelines for the Foot/Ankle Anchors Soft-Tissue Implants, 2023 Coding and Reimbursement Guidelines for the GraftNet Autologous Tissue Collector, 2023 Coding and Reimbursement Guidelines for the IntraOsseous BioPlasty, 2023 Coding and Reimbursement Guidelines for the SpeedBridge Technique, 2023 Coding and Reimbursement Guidelines for the SutureTak, 2023 Coding and Reimbursement Guidelines for the SwiveLock, 2023 Coding and Reimbursement Guidelines for the Syndesmosis TightRope, 2023 Coding and Reimbursement Guidelines for the Univers Revers Total Shoulder System, Cartiform Viable Osteochondral Allograft Reimbursement Guide 2022, Reimbursement Resources Contact Information. Teflon felt adhesion and the sling retraction technique. 2011;4(1):29-41. Lee JY, Parisi TJ, Friedrich PF,et al. CellECT: Cell evolution capturing tool. This product is fully resorbable and does not require removal from the wound bed. An evidence review prepared for the Cochrane Collaboration (Bergin et a., 2006) concluded: "Despite the widespread use of dressings and topical agents containing silver for the treatment of diabetic foot ulcers, no randomised trials or controlled clinical trials exist that evaluate their clinical effectiveness. "SurGraft is directed for use in patients with acute or chronic wounds, including but not limited to, chronic, non-infected, diabetic foot ulcers, chronic, non-infected, partial or full-thickness diabetic foot skin ulcers (due to venous insufficiency), pressure ulcer, surgical wounds and burns which have not adequately responded to conventional therapy." 2016;28(4):119-125. 2018;8(1):e51-e55. Dis Colon Rectum. Am J Sports Med. The development of bioengineered skin. Zelen CM, Serena TE, Denoziere G, Fetterolf DE. J Surg Res. National Institute for Clinical Excellence (NICE). Kaohsiung J Med Sci. 13. Gauglitz GG, Williams FN. Medtech Innovation Briefing [MIB139]. In: BMJ Clinical Evidence. The influence of staple size on fistula formation following distal pancreatectomy. It is packaged as a 200 mg, acellular human placental-derived allograft in a vial which is contained in a peel pouch placed in an outer box. J Surg Oncol. Eaglstein WH, Falanga V. Tissue engineering and the development of Apligraf, a human skin equivalent. 2006;118(1):8-15. A randomized controlled clinical trial of a hypothermically stored amniotic membrane for use in diabetic foot ulcers. Venous ulceration, a relatively common manifestation of venous hypertension, is often refractory to conservative treatment and difficult to treat. London, UK: BMJ Publishing Group; September 2007. Platelet gel for healing cutaneous chronic wounds. FDA Safety Communication: Update on serious complications associated with transvaginal placement of surgical mesh for pelvic organ prolapse. Surg Neurol Int. Until comparative studies of this product have been made available, a thorough evaluation of its safety and effectiveness can not be completed. So K, McGrouther DA, Bush JA, et al. Ulcer duration exceeded 12 months for 50 % of patients in the Apligraf study and was at least 7 months for 47 % of patients in the Oasis study; patients with ulcers exceeding 6 months were excluded from the study of Talymed. Wounds. 2011;66(5):424-428. Hsu PW, Salgado CJ, Kent K, et al. Postoperative cervical cord compression induced by hydrogel (DuraSeal):A possible complication. ProMatrX ACF is a human allograft comprised of amnion and amniotic fluid, providing a liquid allograft to "aid in the healing" and repair of chronic wounds. Federal Register. Barbul A, Gurtner GC, Gordon H, et al. 2012;69(4):347-349. K053655. AmnioMatrix Human Amniotic Suspension Allograft | WoundSource Frykberg RG, Marston WA, Cardinal M. The incidence of lower-extremity amputation and bone resection in diabetic foot ulcer patients treated with a human fibroblast-derived dermal substitute. Boston, MA: Veterans Health Administration Technology Assessment Program (VATAP): January 2003. Madison, WI: Mallinckrodt; revised June 2021. HCPCS Codes Product HCPCS Codes Layer Matrix duration for which standard wound therapy has failed type 1 or type 2 diabetes mellitus with a hemoglobin A1c (HbA1C) less than 12% treated foot has adequate blood supply as evidenced by either the presence of a palpable pedal pulse or an ankle-brachial index (ABI) of 0.70 Bertolli E, Campagnari M, Molina AS,et al. Surg Endosc. A total of 82 patients were analyzed in 2 homogeneous groups. Landsman AS, Cook J, Cook E, et al. VIM human amniotic membrane allograft originates from human tissue and is for homologous use. AETMIS 06-08. Resistance to gapping as measured through normalized stiffness (N/mm/mm) was greater for the Tisseel group, Evicel group, and DuraSeal group versus the no-glue group only. 2012;67(1):15-19. Amputation rates and recidivism at 3 months, 6 months, and 1 year after wound closure were analyzed. The duration of the study was only 3weeks; thus, these researchers relied on surrogate markers for wound healing and only had 4 time-points to examine and compare changes in cytokines, perfusion, and bioburden. Fusion was identified by the absence of abnormal motion of the fused segments on flexion / extension lateral radiographs and the presence of continuous trabecular bone formation at the graft / endplate junction. Public Meeting Agenda for Drugs, Biologicals and Radiopharmaceuticals. Taylor GB, Moore RD, Miklos JR, Mattox TF. U.S. Food and Drug Administration (FDA), Center for Devices and Radiological Health (CDRH). Plast Reconstr Surg Glob Open. 2007;120(2):373-381. 2020a;28(1):81-89. Meschia M, Pifarotti P, Bernasconi F, et al. 510(k) Summary. According to the Human Regenerative Technologies, LLC., WoundFix Plus and BioWound Plus membranes are single layer wound coverings composed of human, chorion-based membranes (CMS, 2019). It is applied over a wound or burn site following wound preparation in multiple sites of care. Homicz MR, Watson D. Review of injectable materials for soft tissue augmentation. Int Wound J. Lecheminant J, Field C. Porcine urinary bladder matrix:A retrospective study and establishment of protocol. Center for Medicare and Medicaid Services (CMS). U.S. Food and Drug Adminstration (FDA). 2014;11(2):122-128. Application Summaries and Coding Decisions Second Quarter 2021 Coding Cycle for Drug and Biological Products. Comparison of AlloDerm and AlloMax tissue incorporation in rats. Application Summaries and Coding Recommendations. Collagen nerve cuff. Publication Date: 6/10/2019. Talymed is placed on the open wound and covered with a transparent dressing. Supplies and Other. Technology Assessment Program: Skin substitutes for treating chronic wounds. Does the addition of a nerve wrap to a motor nerve repair affect motor outcomes? Mil Med. 2015;41:177-188. Bajoghli AA, Yoo JY, Faria DT. Caravaggi C, De Giglio R, Pritelli C, et al. Willett NJ, Thote T, Lin AS, et al. K021792. 2009;22(1):20-24. Dehydrated amniotic membrane allografts for the treatment of chronic wounds: A case series. The 90-day recurrence rates were different for the two groups, with only one recurrence for group A (14.29%) but five recurring ulcers in group B (83.33%). Johnson W, Inamasu J, Yantzer B,et al. Accessed March 2, 2012. 2007;53(6):16-31. J Spinal Disord Tech. Am Surg. 2015;75(3):338-342. Gilbert CL, Gnanapragasam J, Benhaggen R, Novick WM. DeNoto G, 3rd, Ceppa EP, Pacella SJ, et al. Baltimore, MD: CMS; May 20, 2014. Use of fibrin sealants in cardiovascular surgery: A systematic review. 2005;18(5 Pt 1):258-266. Drugs, Biologicals, and Radiopharmaceuticals. 2008;51(5):263-266. London, UK: NICE; March 2013. Collagen matrix for soft tissue reconstruction [website]. 1987;159:127-136. Multicenter postapproval clinical trial of Integra dermal regeneration template for burn treatment. These products are supplied in single use packaging in sizes ranging from .786 to 486 sq. J Wound Care. . 2011;15(5):575-578. The high failure rate of biologic resurfacing of the glenoid in young patients with glenohumeral arthritis. During the healing process, the device is degraded and completely resorbed, leaving new tissue where scar tissue would normally be expected. Biologic meshes are not superior to synthetic meshes in ventral hernia repair: An experimental study with long-term follow-up evaluation. J Pediatr Surg. It is intended for homologous use only. These researchers stated that blinded randomized control trials (RCTs) comparing the effectiveness of skin substitutes and traditional repair methods are imperative for establishing evidence-based guidelines on skin substitute usage following MMS. Collective capabilities of XCelliStems composition include the following activities within the tissue: binding to existing native ECM material, binding to cells, signaling cell attraction, cell mobility, cell growth, and cell differentiation. The investigators noted that significance was not established due to sample size but further investigation with human amniotic allograft is warranted. 2002;961:168-171. Wangensteen KJ, Kalliainen LK. Colorectal Dis. Augmentation of Achilles tendon repair with extracellular matrix xenograft:A biomechanical analysis. 2009;23(4):800-807. #: DOC1-001032-en-USVersion: ALanguage: EnglishRevision Date: 02/22/2023 2023 Coding and Reimbursement Guidelines for FastThread Interference ScrewsFile Type: Ref. Is platelet-rich plasma the perfect enhancement factor? Coding Reference Guide AmnioRepair Allograft is a lyophilized placental membrane allograft that is aseptically processed to preserve the native extracellular matrix and endogenous proteins. Burns. Cytal Burn Matrix is manufactured in multi-layer lyophilized (freeze-dried) sheet configurations. 2004;1(1):21-31. Culligan PJ, Littman PM, Salamon CG,et al. 2012;99(10):1381-1388. Zelen CM, Orgill DP, Serena T, et al. 2010;29(7):893-897. PuraPly AM and PuraPly are supplied in a single-layer or double-layer fenestrated sheet of porcine intestinal collagen, approximately 0.05 to 0.07 rnm in thickness. Ann Plast Surg. Suprathel, a new skin substitute, in the management of donor sites of split-thickness skin grafts: Results of a clinical study. Patel KM, Albino FP, Nahabedian MY, Bhanot P. Critical analysis of Strattice performance in complex abdominal wall reconstruction: Intermediate-risk patients and early complications. Available at: http://www.integra-ls.com/products/?product=274. 2000;16 Suppl 1:S51-S54. Rockville, MD: FDA; December 4, 2008. Clin Interv Aging. Ekhtiari S, Adili AF, Memon M, et al. 2014;23(3):409-419. J Foot Ankle Surg. Derwin KA, Baker AR, Spragg RK,et al. Pittsburgh, PA: Promethean LifeSciences; 2008. Acta Neurochir (Wien). There is insufficient scientific evidence regarding the effectiveness of SurgiMend for use as an implant for the surgical repair of soft tissue deficiencies or for any other indications. 2002;3(7):507; author reply 507-508. A retrospective crossover study of the use of aseptically processed placental membrane in the treatment of chronic diabetic foot ulcers. 2004;62(4):484-488. 2008;106(6):1619-1626. The device used in this study delivered continuous topical oxygen. Arch Bone Jt Surg. Zelen CM, Snyder RJ, Serena TE,et al. 2012;38(3):388-395. Heitland A, Piatkowski A, Noah EM, Pallua N. Update on the use of collagen/glycosaminoglycate skin substitute-six years of experiences with artificial skin in 15 German burn centers. J Extra Corpor Technol. Patton JH Jr, Berry S, Kralovich KA. Arch Orthop Trauma Surg. Both groups received standardized care that included glucose monitoring, weekly debridement's as appropriate, and an offloading device. Eplasty. Integra LifeSciences Corp, Plainsboro, NJ. Multicentre prospective observational study on professional wound care using honey (Medihoney). Hyaluronic acid in the treatment and prevention of skin diseases: molecular biological, pharmaceutical and clinical aspects. Subjects included adults with diabetic foot ulcers one month or more in duration. ANZ J Surg. 2023 Feb 15 [Online ahead of print]. 2016;29:125-134. Project ID: HCPR0610. Additionally, Vende is a structural tissue allograft that is utilized as a skin substituteserving as a protective barrier via resorption into the wound and repairs superficial dermal and soft tissue wounds. These are intended for use as a wound covering, surgical covering, wrap or barrier, application to partial-and full-thickness, acute and chronic wounds such as, traumatic and complex wounds, burns, surgical and Mohs surgery sites and diabetic, venous, arterial, pressure and other ulcers, including with exposed tendon, muscle, bone, or other vital structures. Factors influencing success of pelvic organ prolapse repair using porcine dermal implant Pelvicol. 1998;16(1):11-15. Mesh reinforcement of pancreatic transection decreases incidence of pancreatic occlusion failure for left pancreatectomy:A single-blinded, randomized controlled trial. Statistical analysis was performed via analysis of variance followed by Tukey-Kramer post hoc pair-wise comparison when indicated. Robinson PM, Muir LT. Foreign body reaction associated with Artelon: Report of three cases. InnovaMatrix AC is available for use in your office and wound care clinic.. InnovaMatrix AC is an important and innovative advancement in the treatment of wounds and is available for office use with the HCPCS code A2001. These researchers evaluated 23 patients for 3weeks. Niederauer MQ, Michalek JE, Liu Q, et al. Jeon SH, Lee SH, Tsang YS,et al. 2002;28(8):698-703. Parra MW, Rodas EB, Niravel AA. The use of matriderm and autologous skin graft in the treatment of full thickness skin defects. Ventral herniorrhaphy: Experience with two different biosynthetic mesh materials, Surgisis and Alloderm. Arthroscopy. Dunschede F, et al. Burns. J Bone Joint Surg Am. A novel treatment for venous leg ulcers. Werber and Martin (2013) reviewed the background information and previous clinical studies that considered the use of allogeneic amniotic tissue and fluid (granulized amniotic membrane and amniotic fluid) in the treatment of chronic diabetic foot wounds. Australia and New Zealand Horizon Scanning Network (ANZHSN). 2003;24(9):1549-1557. The mean number of grafts applied was 2. Comparison of different skin preservation methods with gamma irradiation. Stern R, McPherson M, Longaker MT. Efficacy of fibrin sealant (human) (Evicel) in rhinoplasty:A prospective, randomized, single-blind trial of the use of fibrin sealant in lateral osteotomy. 2006;19(6):310-322. 2007;20(2):78-82. 2002;138(6):843-844. Munster AM, Weiner SH, Spence RJ. McCarron JA, Milks RA, Chen X,et al. A prospective, randomized, multicenter trial of Surgisis Gold, a biologic prosthetic, as a sublay reinforcement of the fascial closure after open bariatric surgery. Podiatry Today. Semin Pediatr Surg. Additional Unite Biomatrix may be applied to discrete areas of the wound that have not yet healed satisfactorily. Plast Reconstr Surg. J Hand Surg Am. Zerris VA, James KS, Roberts JB, et al. 2008;6(1). In a prospective, within-subject controlled, randomized, multi-center trial, these researchers examined ReCell in combination with a more widely meshed STSG than a pre-defined SOC meshed STSG (ReCell treatment) for the treatment of mixed-depth burns, including full-thickness (n = 30 subjects). Gariboldi S, Palazzo M, Zanobbio L, et al. Am J Sports Med. Podiatr Manag. The mean patient age was 70 years (range of 6 to 98 years). SurGraft TL is available in a single use package in various sizes. Use of Alloderm in the neurotologic setting. 2011;127(3):1047-1058. A total of 687 patients were included. Arch Surg. It is an absorbable implant that provides a non-constricting, protective encasement for injured tendons and is comprised of a porous matrix of cross-linked bovine Type I collagen and glycosaminoglycan. 2013;17(2):187-191. Repriza is supplied sterile and ready to use in two sizes: 4 x 12 cm and 6 x 16 cm. J Plast Reconstr Aesthet Surg. Huss FR, Nyman E, Gustafson CJ,et al. Utilization of a new tissue expander in the closure of a large Mohs surgical defect. The quantity and size of the product used vary based upon wound size and physician recommendation. Thus, the results of this pivotal study would be considered hypothesis generating. Centers for Medicare & Medicaid Services (CMS). Edmonds M; European and Australian Apligraf Diabetic Foot Ulcer Study Group. Dumville JC, O'Meara S, Deshpande S, Speak K. Alginate dressings for healing diabetic foot ulcers. Epstein NE. Efsandiari S, Dendukuri N, McGregor M. Clinical efficacy and cost of Allogenic Acellular Dermal Matrix (AADM) in implant-based breast reconstruction of post mastectomy cancer patients. It is similar to living skin equivalent (LSE) and provides a supply of living cells, fibroblasts and keratinocytes anda fully developed extracellular matrix (Snyder, et al., 2012). Coding Guides (29) 2023 Coding and Reimbursement Guide for the NanoScope Operative Arthroscopy SystemFile Type: Ref. Billing and Coding: Amniotic Membrane Billing Guidelines for HCPCS Code matrix and endogenous proteins. Eur J Cardiothorac Surg. 2005;26(4):344-347. DiDomenico LA, Orgill DP, Galiano RD, et al. 2010;64(5):674-678. This product requires topical application and is held in place with usual attachment and sterile dressings. Failure of artelon interposition arthroplasty after partial trapeziectomy:A case report with histologic and immunohistochemical analysis. Hernia. Braca JA 3rd, Marzo S, Prabhu VC. Kogan S, Sood A, Granick MS. Amniotic membrane adjuncts and clinical applications in wound healing: A review of the literature. Diabetic foot problems. 2006;118(6):147e-159e. Baltimore, MD: CMS;June 6, 2018. Int Urogynecol J Pelvic Floor Dysfunct. Time to healing in the HSA group was significantly shorter (8.9 weeks) than in the HFDS group (12.5 weeks) (log-rank test, P = 0.0323). 2015;29(2):366.e1-e4. Request to establish a single new Level II HCPCS code to identify two porcine-derived extracellular matrices also known as urinary bladder matrix (UBM), Trade Names: Cytal3L and Cytal6L. The need in dural graft suturing in Chiari I malformation decompression: A prospective, single-blind, randomized trial comparing sutured and sutureless duraplasty materials. Moore MA, Samsell B, Wallis G, et al. The physician will size Restrata to desired configuration of the wound bed and hydrate before appropriate fixation method depending on wound type/location. TEC Assessment Program. 2007;31(10):1966-1972; discussion 1973-1974, 1975. 2007;119(6):1663-1668. Int Wound J. Fibrin sealants or cell saver eliminate the need for autologous blood donation in anemic patients undergoing primary total knee arthroplasty. J Tissue Eng Regen Med. 2014;21(2):137-146. Open-label extension phase of a chronic diabetic foot ulcer multicenter, controlled, randomized clinical trial using cryopreserved placental membrane. Longaker MT, Chiu ES, Harrison MR, et al. Collagen matrix (DuraGen) in dural repair: Analysis of a new modified technique. Hiles M, Record Ritchie RD, Altizer AM. Clin Podiatr Med Surg. Diabetic ulcers were 59 % more likely to close in the treatment cohort compared to the control cohort (p = 0.0045). Ostomy Wound Manage. J Diabetes Science Tech. Apte RS, Solomon SD, Gehlbach P. Acute choroidal infarction following subcutaneous injection of micronized dermal matrix in the forehead region. J Shoulder Elbow Surg. Symbas J, McCord C, Nahai F. Acellular dermal matrix in eyelid surgery. Filgate R, Thomas A, Ballal M. Treatment of foregut fistula with biologic plugs. #: DOC1-000544-en-USVersion: FLanguage: EnglishRevision Date: 02/23/2023 2023 Coding and Reimbursement Guidelines for Metal Compression FT ScrewsFile Type: Ref. 2015;46(1):43-50. 2010;100(1):73-77. Br J Surg. Prescribing Information. Wounds 2017;29(7):E51-E54. Caravaggi C, Francesco Grigoletto M, Scuderi N. Wound bed preparation with a dermal substitute (Hyalomatrix PA) facilitates re-epithelialization and haling: Results of a multicenter, prospective, observational study on complex chronic ulcers: The FAST Study. Thomin A, Touboul C, Hequet D, et al. Prepared by the ECRI Institute Evidence-based Practice Center (EPC) under contract to the Agency for Healthcare Research and Quality (AHRQ), Contract No. Itani KM, Rosen M, Vargo D,et al. Dehydrated human amnion/chorion membrane regulates stem cell activity in vitro. Synovis Surgical Innovations, St. Paul MN. Strong AL, Bennett DK, Spreen EB,et al. Surg Endosc. Single-blind study of manuka honey in allergic fungal rhinosinusitis. IV. 2013;71(2):419-427. Huang H, Kitano K, Nagayama K,et al. Strauss EJ, Verma NN, Salata MJ,et al. Suprathel is available in four sizes: 5 x 5 cm; 9 x 10 cm; 18 x 10 cm; and 18 x 23 cm square sheet membranes. The quantity of product used varies based upon surgical application, individual patient circumstances, and the dimensions of the surgical site. Over the first 16 weeks, patients reported significantly less pain at the ReCell donor sites compared with Controls (p 0.05 at each time-point). Cellesta Flowable Amnion | WoundSource False SAL 10-6 means what? Booth JH, Garvey PB, Baumann DP, et al. Sanchez AR, Sheridan PJ, Kupp LI. 2006;88(12):2665-2672. Sahoo S, DeLozier KR, Erdemir A, Derwin KA. This study considered data from complex wounds typically excluded from controlled trials and supported the idea that real-world evidence studies can be valid and reliable. A systematic review of silver-containing dressings and topical silver agents (used with dressings) for burn wounds. Schlesinger T, Rowland Powell C. Efficacy and safety of a low molecular weight hyaluronic Acid topical gel in the treatment of facial seborrheic dermatitis final report. Adv Skin Wound Care.